Navigating the regulatory do’s and don’ts around controlled substances is an ongoing challenge in veterinary and human medicine. The need to maintain compliance and keep up with 24/7 operations and ever-changing requirements has led to many businesses carving out new positions and departments dedicated to regulatory oversight. Unfortunately, dealing with controlled substances can keep an entire regulatory team busy, which is why adding the gray space of cannabidiol (CBD) can leave even the most compliant health care professionals scratching their heads.
While the demand for CBD products has skyrocketed, regulatory confusion abounds. This is particularly true in the veterinary industry, said Peter Weinstein, DVM, MBA, the owner of PAW Consulting.
“The problem is that clients want to use CBD for their pets, but most veterinarians don’t have enough knowledge regarding the how, when and why when it comes to incorporating CBD into veterinary medicine and negotiating the all-too-fluid laws regarding CBD,” Dr. Weinstein said.
As the demand for CBD surges, so do questions from pet owners. In the end, CBD rules and requirements are very much a gray area. Where does that leave you, the trusted veterinarian?
The Evolution of CBD
Understanding how the market evolved is important. In summary, CBD became available in the human market circa 2012 for use by individuals suffering from severe forms of epilepsy or other critical illnesses. CBD’s early success as an all-natural, homeopathic human treatment alternative, combined with an extensive legal gray area, gave way to a marketplace eruption that saw the arrival of countless CBD brands, products and applications.
Shortly after CBD entered the human homeopathic space, the immersion into veterinary medicine began. CBD pet products boasted “miracle cures” for pain and inflammation, separation anxiety and aggressiveness. CBD became the bright, shiny new object that everyone wanted a piece of, further driving pet owners to ask their veterinarians for more information.
As the lack of clarity mounted among pet owners, clients increasingly pressed their veterinarians to recommend CBD as an alternative treatment regimen. Practitioners looked for answers from regulatory authorities, who not only struggled to provide guidance but also often gave conflicting answers. All this forced pet owners and veterinarians into a gray area of uncertainty and confusion. Veterinarians also face potential exposure professionally and legally.
A Trifecta of Regulatory Requirements
Think of regulatory requirements as a triangle split into three horizontal sections — a base, middle and top. Federal regulations form the base because they represent the minimum requirements that all state and local laws must follow. In the middle are the laws enacted by states, which are empowered to impose requirements more stringent than what the federal government requires. At the top are local laws, which like state laws, cannot violate federal laws. Also, local laws may not violate state laws but may be stricter.
Hemp-Derived CBD
Dec. 20, 2018, was a landmark date in the CBD arena because that’s when the Agriculture Improvement Act of 2018 (Farm Bill) was signed into federal law. Part of the Farm Bill included the legalization of hemp-derived CBD in the United States.
Hemp-derived CBD is sourced from industrial hemp plants, which are grown primarily for their fiber and seeds. According to federal regulations, the government classifies hemp as any plant of the cannabis family containing less than 0.3% THC and marijuana as any plant of the cannabis family with greater than 0.3% THC. Under U.S. law, hemp-derived CBD is legal.
Here is a summary of Farm Bill regulations concerning hemp-derived CBD:
- Even if a CBD product meets the definition of hemp-derived under the Farm Bill, it must comply with all other applicable federal laws, including the Federal Food, Drug and Cosmetic Act.
- Purchasing and consuming hemp-derived CBD is federally legal in all 50 states.
- Buying hemp-based CBD online and shipping it is federally legal.
- Under federal law, any CBD food, beverage or supplement may not be distributed via interstate commerce without Food and Drug Administration approval.
FDA = More Gray
While the purchase and consumption of hemp-derived CBD is legal at the federal level, anything that involves food and dietary products falls under the authority of the FDA, and the FDA has repeatedly stated that CBD may not be used in food or dietary supplements sold across state lines.
Only one FDA-approved CBD prescription product is available on the human market: Epidiolex, which contains a purified form of CBD and is used primarily to treat seizures in patients 2 years or older.
State Regulations
To varying degrees, all states have their own way of doing things. As long as state law does not violate the baseline federal regulatory requirements, federal law cannot preempt state laws. Below are several examples showing how widely state CBD regulations can vary. While hemp-derived CBD is federally legal in all 50 states, some states, such as Idaho, go in another direction.
Idaho
While the Farm Bill legalized hemp-derived CBD with less than .03% THC, Idaho allows residents to use or buy only CBD products containing 0% THC. This law, therefore, precludes the use of full-spectrum CBD products that naturally contain small amounts of THC. If you live in or practice veterinary medicine in Idaho, your CBD options are limited isolate products, which means the CBD cannabinoid is completely isolated out and removed from other full-spectrum cannabinoids and cannabis compounds like terpenes and flavonoids. All this results in a THC-free product.
California
California is a trailblazer from a regulatory standpoint. Still, CBD laws in California tend to be pretty strict. Currently, cannabis is illegal for use in veterinary medicine throughout the state. While legislative efforts seek to expand how veterinarians can work with cannabis products, the existing law limits veterinarians to discussing CBD products with clients but not recommending or dispensing them.
Michigan
In December 2020, Michigan made a groundbreaking move when Gov. Gretchen Whitmer signed a bill allowing veterinarians to consult with pet owners on the use of marijuana and hemp products, including cannabidiol, for animals. While Michigan veterinarians can recommend or advise against the use of therapeutic cannabis products for animals, existing state law bans the sale of CBD animal feed and pet food products, including CBD treats. According to the Michigan Department of Agriculture and Rural Development, “Safe levels for animal consumption have not been established.”
Local Ordinances
As noted above, certain municipalities will enforce more stringent laws beyond what their state enacted. Local ordinances are in effect on varying levels in cities such as Los Angeles, Dallas and Chicago.
The CBD landscape remains gray, but the regulations are constantly evolving and legislative patterns suggest that progress is being made.
HELPFUL TIPS
I have helped veterinarians from New York to Hawaii comply with U.S. Drug Enforcement Administration regulations. But when it comes to state regulatory compliance and cannabis requirements, I’ve learned that all hands on deck is the norm for veterinary professionals. Practice owners always have critical issues to deal with, so don’t waste time searching for answers in the wrong places. Here are my suggestions regarding CBD and the practice of veterinary medicine.
- Be prepared: Expect CBD inquiries from pet owners. Whether you are using CBD in veterinary medicine, recommending it or considering doing so, make sure you have your compliance bases covered on the federal, state and local levels.
- Be informed: Regulations are constantly changing, which is why you need to stay on top of all applicable laws. Also, don’t forget that your state veterinary medical board ultimately oversees your license and practice.
- Be protected: Until the U.S. Food and Drug Administration settles on a national CBD regimen, veterinary professionals working with CBD accept a certain level of risk. At the end of the day, the FDA runs the show and a state law saying you can use or recommend CBD does not necessarily protect you. As a best practice, make sure to consult with an attorney and your state regulatory agencies before you make a decision that could put you in a compromising position.
- Be methodical: In other words, treat CBD no differently than any other controlled substance with which you would consider working. Do your research. Weigh the pros, cons, side effects and most effective utilizations for the patients you intend to treat.